Assoc. Spclst, Quality Control

Carlow
Permanent
Full-time

6 days ago

Job DescriptionA fantastic opportunity has arisen Stability Associate Specialist, Quality Control. The stability associate specialist will work as part of the integrated stability operations & compliance team and drive a culture of quality and operational excellence within the team. The stability associate specialist will support GMP stability studies and logistics in collaboration with our global stability team.Bring energy, knowledge, innovation to carry out the following:

Coordinate site stability activities, reviews and approves all product stability protocols, ensure all stability sample numbers are communicated to the relevant department. Ensures all in-house stability testing is reported out within the required time frames.
Participate in GMP stability studies, including detailed planning, coordination across networks, and implementation of stability studies for sites product portfolio, in accordance with all applicable regulatory requirements.

Collaboration with internal and external partners in a cross-functional environment to drive compliance and operational excellence for stability studies.

Evaluation of stability data, investigating out of specification stability results, and communication with integrated project teams for biologics, vaccines, and/or devices.

Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems (e.g., LIMS, and electronic document management systems).

Execute deviations and investigations, Change Management records, support GMP documentation including stability protocols, Standard Operating Procedures (SOP), and GMP data management.

Facilitate and drive effective communication to ensure success.
Support authoring and approval of Annual Product Review

Assessment of stability impact as a result of Pharmacopeia and Quality standard updates

Participate in thorough Investigations in the stability area, ensuring effective CAPA implementation in a timely manner and meeting site KPI’s

Participate in improvement projects and QC Hoshins within the area.

Support stability investigations through root cause analysis tools and 8 -step problem solving.
May be required to perform other duties as assigned.

What skills you will need:In order to excel in this role, you will more than likely have:

2-4 years’ experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes experience in a Quality function.
Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
Degree in Science, Engineering or similar
Lean Six Sigma Yellow Belt or suitable alternative
Knowledge of cGMP in Laboratory Quality Systems.
Knowledge of stability requirements.
Proficiency in Microsoft Office and job-related computer applications required
Demonstrated experience in Report, standards, policy writing
Understanding of Lean Six Sigma Methodology preferred.
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Good communication, interpersonal skills and ability to work across teams.
Demonstrated ability to drive the completion of tasks
Proven decision-making capability with accountability and responsibility

The Carlow site broke ground in 2008 and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product. Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units. The Carlow site is a significant employer in the South East region and attracts high performing talent through close collaborations with universities and colleges in the region.As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. Please don't hesitate to contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.Required Skills: Data Analysis, GLP Regulations, GMP Compliance, IS Audit, Technical Procedures, Technical Writing, Ultraviolet Visible SpectroscopyPreferred Skills:Current Employees applyCurrent Contingent Workers applySearch Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: No relocationVISA Sponsorship: NoTravel Requirements: 10%Flexible Work Arrangements: HybridShift: 2nd - EveningValid Driving License: NoHazardous Material(s): NoJob Posting End Date: 04/23/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

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